Regulatory Medical Writing
High-quality regulatory documentation for successful submissions. Expert medical writers delivering clear, compliant, and scientifically accurate regulatory documents.
Professional Medical Writing Services
Comprehensive documentation support for regulatory success
Regulatory Dossiers
Preparation of complete regulatory dossiers in CTD, eCTD, and local formats. We ensure all modules meet regional requirements and quality standards.
Clinical Study Reports
Comprehensive clinical study reports following ICH E3 guidelines. We transform complex clinical data into clear, regulatory-compliant narratives.
Investigator Brochures
Development of comprehensive investigator brochures for clinical trials. We compile and present safety and efficacy data in accessible formats.
Clinical Protocols
Design and writing of robust clinical trial protocols. We ensure scientific rigor while maintaining clarity and regulatory compliance.
Summary Documents
Expert preparation of clinical and non-clinical summaries, overviews, and expert reports for regulatory submissions.
Document Review & Editing
Quality review and editing of existing regulatory documents. We ensure consistency, accuracy, and compliance with current guidelines.
Our Writing Process
Systematic approach to regulatory documentation
Project Planning
Define scope, timelines, and deliverables
Data Collection
Gather and review source documents
Drafting
Prepare initial document drafts
Review & Revision
Internal QC and client review cycles
Finalization
Deliver publication-ready documents
Elevate Your Regulatory Documentation
Partner with ECP for expert medical writing services across Africa
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